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Rogaine Rx-to-OTC switch clears advisory committee based on label comprehension study.

This article was originally published in The Rose Sheet

Executive Summary

ROGAINE OTC LABEL COMPREHENSION STUDIES SUPPORT APPROVAL RECOMMENDATION from FDA's Nonprescription Drugs and the Dermatologic and Ophthalmic Drug Advisory Committees Nov. 17. A Pharmacia & Upjohn label comprehension study found the Rogaine OTC label effectively communicated to consumers "realistic efficacy expectations, consequences of noncompliance, [the] long-term nature of the product," and "when to seek medical advice," the firm said.
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